- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404958
Systems Analysis and Improvement Approach to Improve Integration of HIV Prevention and Treatment Services (FP HIV SCALE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
AIM 1: To conduct a cluster-randomized trial evaluating the effectiveness of SAIA versus control (usual procedures) for increasing HIV counseling, testing, linkage to care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients. Quantitative and qualitative data will be analyzed using the RE-AIM framework (21).
1a) Reach: Proportion of intervention arm health facility clients' reached with the intervention
1b) Effectiveness: Compare the effectiveness of SAIA vs. control for increasing rates of HIV counseling, testing, linkage to care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients
1c) Adoption: Proportion of clinics adopting SAIA; adoption determinants identified using the Implementation Research Logic Model (IRLM) (22) and Organizational Readiness for Implementing Change (ORIC) scale (23)
1d) Implementation: Proportion of FP clinics implementing SAIA with high fidelity at 12 months and at 24 months; barriers and facilitators of implementation at scale by County DOH personnel will be explored using constructs from the Consolidated Framework for Implementation Research (CFIR) and the IRLM (24)
1e) Maintenance: Proportion of FP clinics maintaining SAIA at 12 months and 24 months after introduction AIM 2: To estimate the incremental cost and budget and program impacts of SAIA from a County DOH perspective. We will conduct activity-based costing and develop budget impact scenarios based on SAIA's adoption.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: McKenna Eastment
- Phone Number: 206-4165074
- Email: mceast@uw.edu
Study Locations
-
-
-
Mombasa, Kenya
- FP Clinics in Mombasa County
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
FP clinics:
-All FP clinics that receive County-supplied FP products will be eligible to participate.
FP clinic managers and staff:
-Any FP clinic manager that is 18 years and older is eligible to be interviewed. -These clinic managers can be male or female.
Kenyan public health staff:
- Any Kenyan public health staff that is 18 years and older is eligible to be interviewed.
- These public health staff can be male or female.
Exclusion Criteria:
FP clinics:
- Any clinics that are expected to close within the next year at the time of study initiation
- 12 facilities that participated as SAIA intervention facilities in our small-scale trial where the intervention was led by research staff.
FP clinic managers and staff: No exclusion criteria Kenyan public health staff: No exclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention clinics that implement the Systems Analysis and Improvement Approach
Mombasa County public health staff will facilitate SAIA
|
What is SAIA? It is a 5-step cycle that is repeated every 4-6 weeks for continuous quality improvement, implemented by Kenyan public health workforce and FP clinic staff, and monitored by Mombasa DOH. Step 1: Understanding the cascade from FP clinic enrollment to HIV testing to linkage to treatment and prevention services. Step 2: Use process mapping to identify modifiable bottlenecks. Step 3: Define and implement workflow adaptations to eliminate modifiable bottlenecks. Step 4: Monitor change in performance. Step 5: Repeat the analysis and improvement cycle (steps 1-4). |
No Intervention: Usual procedures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reach HIV counseling
Time Frame: Months 1-12
|
Proportion of FP clients in intervention clinics counseled for HIV out of the total FP clients seen in the clinic
|
Months 1-12
|
Effectiveness HIV counseling
Time Frame: Months 1-12
|
Proportion of FP clients (counseled for HIV out of the total FP clients seen in the clinic in intervention vs control clinics
|
Months 1-12
|
Reach HIV testing
Time Frame: Months 1-12
|
Proportion of FP clients in intervention clinics counseled for HIV out of the total FP clients seen in the clinic
|
Months 1-12
|
Effectiveness HIV testing
Time Frame: Months 1-12
|
Proportion of FP clients tested for HIV out of the total FP clients who should be tested in intervention vs control clinics
|
Months 1-12
|
Reach Linked to HIV care
Time Frame: Months 1-12
|
Proportion of HIV seropositive FP clients who are out of care linked to comprehensive HIV care in intervention clinics out of all HIV seropositive FP clients who are out of care
|
Months 1-12
|
Effectiveness Linked to HIV care
Time Frame: Months 1-12
|
Proportion of HIV-seropositive FP clients who are out of care then linked to comprehensive HIV care out of all HIV-seropositive FP clients who are out of care in intervention vs control clinics
|
Months 1-12
|
Reach Screening and linkage to PrEP
Time Frame: Months 1-12
|
|
Months 1-12
|
Effectiveness Screening and linkage to PrEP
Time Frame: Months 1-12
|
1. Proportion of HIV-seronegative FP clients screened for PrEP out of all HIV-seronegative FP clients in intervention vs control clinics 2. Proportion of HIV-seronegative FP clients who are eligible for PrEP who are linked to PrEP out of all HIV-seronegative FP clients who are eligible for PrEP in intervention vs control clinics 2. Proportion of HIV seronegative FP clients eligible for PrEP in intervention clinics who are linked to PrEP out of all HIV seronegative FP clients eligible for PrEP
|
Months 1-12
|
Adoption
Time Frame: 12 months
|
1. Proportion of intervention clinics that participated in the initial training and selected their first micro-intervention
|
12 months
|
Adoption
Time Frame: 12 months
|
2. In-depth interviews using the IRLM and CFIR; Administer survey using the ORIC assessment
|
12 months
|
Implementation
Time Frame: 12 months
|
1a. Proportion of intervention clinics implementing SAIA with high fidelity 1b. Proportion of intervention clinics implementing SAIA with low fidelity |
12 months
|
Implementation
Time Frame: 24 months
|
1a. Proportion of intervention clinics implementing SAIA with high fidelity 1b. Proportion of intervention clinics implementing SAIA with low fidelity |
24 months
|
Implementation
Time Frame: 12 months and 24 months
|
2. In-depth interviews with FP clinic staff in intervention clinics and county and national personnel using IRLM and CFIR.
|
12 months and 24 months
|
Maintenance
Time Frame: 12 & 24 months
|
1a. Proportion of FP clinics with sustained maintenance 1b. Proportion of FP clinics with partial maintenance |
12 & 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: McKenna Eastment, MD, MPH, University of Washington
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00014745
- GRANT13455302 (Other Grant/Funding Number: NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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